Study on Gemcitabine, Docetaxel, and Toripalimab for Epstein-Barr Virus Associated Nasopharyngeal Cancer

Inclusion Criteria

• Have advanced nasopharyngeal cancer associated with Epstein-Barr Virus (EBV) at specific stages.
• Have not received any prior treatment for nasopharyngeal cancer.
• Have a life expectancy of at least 3 months.
• Agree to use effective birth control during treatment and for 4 months after the last dose if you are a woman of childbearing potential or a sexually active man.
• Have an ECOG performance status of 0, 1, or 2, indicating full activity or some restriction in physically strenuous activity.
• Be at least 18 years old.
• Have adequate blood cell counts, including:
  • Neutrophil count of at least 1,500 cells/mm³.
  • Platelet count of at least 100,000 cells/mm³.
  • Hemoglobin level of at least 8.0 g/dL (transfusions are allowed to meet this level).
• Have adequate liver function, with:
  • Total bilirubin level within 1.5 times the normal limit.
  • AST and ALT levels within 1.5 times the normal limit.
• Have adequate kidney function, with:
  • Serum creatinine level within 1.5 mg/dL or creatinine clearance of at least 50 ml/min.
• Women of childbearing potential must have a negative pregnancy test before starting treatment.
• Be able to understand and willing to sign a consent form to participate in the study.

Exclusion Criteria

• Have received any previous systemic treatment for nasopharyngeal cancer.
• Have had radiation treatment to the head and neck area that overlaps with the study treatment area.
• Are currently using any other cancer treatments, whether standard, alternative, or experimental.
• Have a history of allergic reactions to any of the study drugs.
• Have an autoimmune disease or have had an organ transplant that could increase the risk of treatment.
• Are pregnant or breastfeeding.
• Have severe, active medical or psychiatric conditions that could interfere with the study, such as:
  • Unstable heart conditions or heart failure within the past 6 months.
  • Recent heart attack within the last 6 months.
  • Active infections requiring intravenous antibiotics, unless controlled.
  • Severe lung conditions requiring hospitalization within 30 days before starting treatment.
• Have AIDS, as the treatment may weaken the immune system further.
• Have significant hearing loss that affects daily activities, unless it is related to the tumor.
• Have moderate to severe nerve damage affecting sensation.